MAUDE Adverse Event Report: PARKER MEDICAL PARKER; ENDOTRACHEAL TUBE, HIGH VOLUME LOW PRESSURE (PFHV), CUFFED, PARKER, 8.5MM

Model Number	H-PFHV-85
Medical Device Problem Codes	Mechanical Problem (1384); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Cuff leaking during intubation.Patient cannot be ventilated adequately.
Additional Manufacturer Narrative
H6: 4756 (appropriate impact term/code not available): endotracheal tube.The product involved in the report has not been returned.A review of the device history record is in-progress.All information reasonably known as of 06 dec 2024 has been included in the health authority report.Should additional information be obtained a follow-up health authority report will be provided.The information provided by airlife represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to airlife.Airlife has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the airlife complaint database and is identified as complaint - (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that a airlife product is defective or causes serious injury.
Additional Manufacturer Narrative
H6: 4756 (appropriate impact term/code not available): endotracheal tube the product involved in the report has not been returned.A review of the device history record is in-progress.All information reasonably known as of (b)(6) 2024 has been included in the health authority report.Should additional information be obtained a follow-up health authority report will be provided.The information provided by airlife represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to airlife.Airlife has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the airlife complaint database and is identified as complaint - (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that a airlife product is defective or causes serious injury.The complaint investigation was performed based on the content of the issue reported.Based on the complaint report no patient was affected.The complaint investigation was performed based on the content of the issue reported.Based on the complaint report no patient was affected.The customer did not provide photo images of the issue; therefore, the complaint could not be confirmed.However, a supplier corrective action report scar24-003 that has been initiated to well lead to further investigate the leak issue.A risk assessment was performed, and the ultimate risk was determined to be low which does not require reporting to the capa review board.This is the first complaint reported for part number i-pfhv-85.There were no other complaints reported for part number i-pfhv-85 during the same timeframe.Due to a trend for leaks scar24-003 has been initiated.A resolution letter was sent to the customer.We will continue to monitor trends during our periodic complaint review meetings.
Event or Problem Description
Cuff leaking during intubation patient cannot be ventilated adequately.

• Brand Name: PARKER
• Common Device Name: ENDOTRACHEAL TUBE, HIGH VOLUME LOW PRESSURE (PFHV), CUFFED, PARKER, 8.5MM
• Manufacturer (Section D): PARKER MEDICAL; 9457 s university blvd; pmb 331; highlands ranch CO 80126
• Manufacturer (Section G): WELL LEAD MEDICAL CO; c-4 jinhu industrial estate; hualong; panyu, guangzhou 51143 4; JA 511434
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 20872621
• Report Number: 3000219639-2024-00139
• Device Sequence Number: 18350674
• Product Code: BTR
• UDI-Device Identifier: 00607411952760
• UDI-Public: (01)00607411952760(10)2307HV1544N
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K984528
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: H-PFHV-85
• Device Catalogue Number: H-PFHV-85
• Device Lot Number: 2307HV1544N
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2024
• Supplement Date Received by Manufacturer: 11/06/2024
• Initial Report FDA Received Date: 12/06/2024
• Supplement Report FDA Received Date: 02/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown